Orexo initiates exploratory feasibility studies of amorphOX[®] with two leading biopharmaceutical and vaccine companies

• Orexo has successfully formulated Covid-19 spike protein in the proprietary drug delivery platform amorphOX®, showing excellent protein stability
• Orexo has initiated two exploratory feasibility studies applying amorphOX^® to a protein based pharmaceutical and a vaccine in collaboration with leading international biopharmaceutical and vaccine companies
• Orexo has patent applications for amorphOX^® formulations relating to biomolecules

Uppsala, Sweden – January 9, 2023 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces the company has initiated two exploratory feasibility studies, applying the proprietary drug delivery platform amorphOX^® to protein based pharmaceuticals and vaccines in collaboration with leading international biopharmaceutical and vaccine companies. The feasibility studies follow successful formulation of the Covid-19 spike protein in amorphOX^®.  

Orexo has expanded the application of the amorphOX^® platform, from small molecules to also cover larger biomolecules. The company has tested enzymes, peptides and proteins in amorphOX^® and seen significant improvement in stability compared to other formulations in a wide range of storage temperatures. In the recent study with Covid-19 spike protein, Orexo measured the activity level of the protein after one month storage in both intermediate and high temperatures. Data showed formulations based on amorphOX^® managed to fully maintain activity levels after one month, even at high storage temperature. 

amorphOX® has also been tested in multiple clinical studies with several different APIs (Active Pharmaceutical Ingredients) and consistently showed superior nasal absorption and bioavailability to competing drug delivery technologies. To test the ability of amorphOX^® as a platform for biopharmaceuticals, Orexo will work with companies having unique biomolecules or technologies.

Today’s announcement of collaborations with two leading international biopharmaceutical and vaccine companies is based on shared risk projects, where the parties will assess the feasibility of the biomolecules supplied by the partners in amorphOX^® formulations. Orexo will lead the formulation and manufacturing work, whereas the partner will be responsible for testing the product and to assessing future commercial opportunities of a partnership. 

Nikolaj Sørensen, President and CEO of Orexo, said, “amorphOX^® is the cornerstone in Orexo’s pipeline projects and I am pleased to see how the unique properties of amorphOX^® in nasal delivery, bioavailability and storage stability have been recognized by leading biotech companies. Many biomolecules have issues with storage and often requires injections to deliver the medication. If amorphOX^® can enable nasal delivery and stability in room temperature this could be a significant improvement for many of these products and expand availability of life saving medicines and vaccines to new groups. Orexo’s ambition is to work with leading companies to test the feasibility of the amorphOX^® platform on their biomolecule or technology. If successful, these projects will advance into revenue generating partnering agreements.”  

Orexo AB (publ.)

About amorphOX^®

Orexo’s proprietary drug delivery platform, amorphOX^®, is a powder made up of particles which are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, as well as rapid dissolution. The technology works for a broad scope of active ingredients and has been validated in several human clinical studies showing rapid and extensive drug exposure.

About Orexo

Orexo develops improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental health. The products are commercialized by Orexo in the US or via partners worldwide. The main market today is the American market for buprenorphine/naloxone products, where Orexo commercializes its lead product ZUBSOLV® for treatment of opioid use disorder. Total net sales for 2021 amounted to SEK 565 million and the number of employees was 121. Orexo is listed on the Nasdaq Stockholm Mid Cap (ORX) and is available as ADRs on OTCQX (ORXOY) in the US. The company is headquartered in Uppsala, Sweden, where research and development activities are performed.

For more information about Orexo please visit www.orexo.com. You can also follow Orexo on Twitter, @orexoabpubl, LinkedIn, and YouTube.

The information was submitted for publication at 8.00 CET on January 9, 2023